Global Harmonization of Pediatric Drug Development: Critical for Progress for Developing Safe and Effective Therapeutic Agents for Children.

The article, "Questionable Industry-Sponsored Studies in Children and Adolescents in Slovenia" provides an opportunity to discuss evolving US and EU legislative measures to improve the available clinical trial-derived pediatric data and provide coherent labeling for pediatric providers in dosing of drugs for children.

Physiological effects of titrated oxygen via nasal high-flow cannulae in COPD exacerbations: A randomized controlled cross-over trial.

Background And Objective: Increased arterial carbon dioxide tension (PaCO ) is an important complication of acute exacerbations of COPD. The effects of nasal high-flow cannulae (NHF) on PaCO in patients with COPD exacerbations, and whether this therapy should be used in this clinical situation, are less certain. We aimed to investigate the effect of NHF on PaCO in patients admitted to hospital with a COPD exacerbation.

Day-time variation of serum periostin in asthmatic adults treated with ICS/LABA and adults without asthma.

Background: We aimed to determine the effect of sampling time during the day on serum periostin levels in adult participants with and without asthma.

Methods: Serum periostin was measured at 2-h intervals from 0800 to 1800 h in 16 adult participants with stable asthma prescribed inhaled corticosteroid and long-acting beta-agonist therapy, and in 16 otherwise healthy participants without asthma. Mixed linear models were used to compare time zero (08:00 h) with subsequent measurement time for serum periostin for both groups.

Reference ranges for serum periostin in a population without asthma or chronic obstructive pulmonary disease.

Background: The clinical utility of serum periostin as a type 2 biomarker in asthma is limited by lack of reference range values derived from a population without respiratory disease.

Objective: To derive age- and sex-related reference intervals for serum periostin from an adult population without asthma or COPD.

Methods: Serum periostin levels were measured in 480 individuals, comprising 60 female and 60 male adults in each of the 18- to 30-year, 31- to 45-year, 46- to 60-year and 61- to 75-year age groups.

Tolerability of Nasal Delivery of Humidified and Warmed Air at Different Temperatures: A Randomised Double-Blind Pilot Study.

Objectives: Delivery of warmed, humidified air via nasal high flow therapy could potentially reduce replication of temperature-sensitive viruses in the upper respiratory tract. This study investigates whether nasal high flow therapy is well tolerated by healthy adults at 37°C and 41°C.

Methods: In this randomised, double-blind, controlled crossover pilot trial, nasal high flow therapy was used to deliver humidified air at 35 L/min, at either 37°C or 41°C, for three one-hour sessions of use over one day.